IN THE

SUPREME COURT OF CALIFORNIA

T.H., A MINOR, ET AL.,

Plaintiffs and Appellants,

v.

NOVARTIS PHARMACEUTICALS CORPORATION,

Defendant and Respondent.

Review of a decision of the Court of Appeal, Fourth Appellate District, Division One

Case No. D067839

Plaintiffs’ Consolidated Answer to

Amicus Curiae Briefs in Support of Respondent

Leslie A. Brueckner, Esq. PUBLIC JUSTICE, P.C.

555 12TH Street, Suite 1230 Oakland, California 9460

Tel: (510) 520-6205 Fax: (510) 622-8155

Benjamin I. Siminou, Esq. THORSNES BARTOLOTTA MCGUIRE LLP

2550 Fifth Avenue, 11th Floor San Diego, California 92103

Tel: (619) 236-9363 Fax: (619) 236-9653

Attorneys for Plaintiffs and Appellants T.H., a Minor, et al.

S233898

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TABLE OF CONTENTS

Argument.......................................................................................................1

I. Brand-Name Liability Is Entirely Consistent with California Tort Law ............................................................................1 A. Novartis Can Be Held Liable Even Though

It Did Not Manufacture the Drug That Injured Plaintiffs ....................................................................................1 1. Plaintiffs Seek Recovery for Negligent

Misrepresentation Under Section 311 of the Restatement of Torts ......................................................1

2. Negligent Misrepresentation Claims Are Not Subject to an Instrumentality Requirement .................3

3. Negligent-Misrepresentation Claims Are Not “Substantively Indistinguishable” from Product-Liability Claims .......................................6

4. Amici’s “Instrumentality” Case Law Does Not Help Its Cause .........................................................11

5. Amici’s Policy Arguments in Support of their “Instrumentality” Theory Lack Merit ..............15

B. The Rowland Factors Counsel in Favor of Recognizing a Duty of Care in this Case ......................................................18

1. Amici’s “Foreseeability” Arguments Lack Merit ...........19

2. Amici’s Public Policy Arguments Do Not

Justify a Categorical Exception to the Duty of Care .............................................................................21 a. Prevention of Future Harm ..................................21

b. Burden on the Defendant .....................................30

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c. Consequences to the Community .........................35

d. Availability of Insurance ......................................39

C. Amici’s Out-of-State Authority is Distinguishable or Unpersuasive ........................................................................40

II. “Former” Manufacturer Liability is Consistent with California Tort Law ............................................................................49 A. Foreseeability ............................................................................50

B. Closeness of Connection ...........................................................51

C. Moral Blameworthiness of the Defendant...............................52

D. Burden on the Defendant .........................................................54

E. Prevention of Future Harm ......................................................55

F. Consequences to the Community .............................................62

G. Availability of Insurance ..........................................................67

Conclusion .....................................................................................................71

Certificate of Compliance .............................................................................72

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TABLE OF AUTHORITIES

Cases

Althaus v. Cohen (2000) 562 Pa. 547 .......................................................................................... 35

Anselmo v. Sanofi–Aventis Inc. (Kan. Dist. Ct. Oct. 13, 2014, No. 10-CV-77) 2014 WL 8849464 ........... 37, 39

Baymiller v. Ranbaxy Pharmaceuticals, Inc.

(D. Nev. 2012) 894 F.Supp.2d 1302 ......................................................... 36, 37

Beacon Residential Community Assn. v. Skidmore, Owings & Merrill LLP (2014) 59 Cal.4th 568 ..................................................................................... 45

Bell v. Pfizer, Inc. (8th Cir. 2013) 716 F.3d 1087 ........................................................................ 38

Blecker v. Wolbart (1985) 167 Cal.App.3d 1195 ........................................................................... 59

Bristol–Meyers Squibb Co. v. Superior Court (2016) 1 Cal.5th 783 ....................................................................................... 28

Burke v. Wyeth, Inc. (S.D. Tex. Oct. 29, 2009, No. G-09-82) 2009 WL 3698480 ........................... 37

Cabral v. Ralphs Grocery Co. (2011) 51 Cal. 4th 764 .................................................................................... 16

Carlin v. Superior Court (1996) 13 Cal.4th 1104 ............................................................................ passim

Chatman v. Pfizer, Inc. (S.D. Miss. 2013) 960 F.Supp.2d 641 ............................................................ 41

Clark v. Pfizer, Inc. (Pa. Ct. Co. Pl. 2008, No. 1819) 2008 WL 7668730 ...................................... 41

Colaccio v. Apotex, Inc. (E.D. Pa. 2006) 432 F.Supp.2d 514 ............................................................... 35

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Conte v. Wyeth (2008) 168 Cal.App.4th 89 ...................................................................... passim

Demay v. Scharz Pharma, Inc. (5th Cir. 2012) 702 F.3d 177 .......................................................................... 38

Dolin v. SmithKline Beecham Corp. (N.D. Ill. 2014) 62 F.Supp.3d 705 .................................................................. 41

Drexler v. Petersen (2016) 4 Cal.App.5th 1181 ............................................................................. 58

Eckhardt v. Qualitest Pharmaceuticals, Inc. (5th Cir. 2014) 751 F.3d 674 .......................................................................... 38

Finnicum v. Wyeth, Inc. (E.D. Tex. 2010) 708 F.Supp.2d 616 .............................................................. 37

Fisher v. Pelstring (D.S.C. July 28, 2010, No. 4:09-cv-00252-TLW) 2010 WL 2998474 ............ 40

Flynn v. American Home Products Corp.

(Minn. Ct. App. 2001) 627 N.W.2d 342 ......................................................... 37

Foster v. American Home Products, Inc., 29 F.3d 165 (4th Cir. 1994) ..................................................................... passim

Franzman v. Wyeth (Mo. Ct. App. 2014) 451 S.W.3d 676.............................................................. 37

Fullington v. Pfizer, Inc. (8th Cir. 2013) 720 F.3d 739 .......................................................................... 38

Garcia v. Superior Court (1990) 50 Cal.3d 728 ........................................................................... 3, 4, 5, 11

Gardley-Starks v. Pfizer, Inc. (N.D. Miss. 2013) 917 F.Supp.2d 597 ............................................................ 37

Greenman v. Yuba Power Prods. (1963) 59 Cal. 2d 57 .......................................................................................... 6

Gross v. Pfizer, Inc. (D. Md. Nov. 9, 2010, No. 10-CV-00110-AW) 2010 WL 4485774 ................. 40

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Guarino v. Wyeth, LLC

(11th Cir. 2013) 719 F.3d 1245 ...................................................................... 40

Hanberry v. Hearst Corp. (1969) 276 Cal.App.2d 680 ........................................................................... 2, 9

Hardy v. Wyeth, Inc. (E.D. Tex. Mar. 8, 2010, No. 9:09CV152) 2010 WL 1049588 ....................... 38

Howe v. Wyeth, Inc.

(M.D. Fla. Apr. 26, 2010, No. 8:09-CV-610-T-17AEP) 2010 WL 170885 .... 40 Huck v. Wyeth, Inc.,

850 N.W.2d 353 (Iowa 2014) ................................................................... passim

In re Darvocet (6th Cir. 2014) 756 F.3d 917 .................................................................... 18, 39

Johnson v. American Standard, Inc. (2008) 43 Cal.4th 56, 65 ................................................................................. 14

Johnson v. Teva Pharmaceuticals USA, Inc. (5th Cir. 2014) 758 F.3d 605 .......................................................................... 38

Kellogg v. Wyeth, Inc. (D. Vt. 2010) 762 F.Supp.2d 694 ............................................................. 41, 42

Kesner v. Superior Court (2016) 1 Cal. 5th 1132 ............................................................................. passim

Lashley v. Pfizer, Inc. (5th Cir. 2014) 750 F.3d 470 .......................................................................... 38

Levine v. Wyeth, Inc. (M.D. Fla. 2010) 684 F.Supp.2d 1338............................................................ 40

Meade v. Parsley (S.D. W.Va. Nov. 13, 2009, No. 2:09-cv-00388) 2009 WL 3806716 .............. 40

Mensing v. Wyeth, Inc. (8th Cir. 2009) 588 F.3d 603 .............................................................. 36, 37, 38

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Merrill v. Navegar (2001) 26 Cal.4th 465 ............................................................................... 10, 11

Metz v. Wyeth, Inc. (M.D. Fla. 2011) 830 F. Supp. 3d 1291.......................................................... 40

Moretti v. Wyeth (9th Cir. 2009) 579 F. App’x 563 .............................................................. 36, 38

O’Neil v. Crane Co. (2012) 53 Cal.4th 335 ....................................................................... 8, 9, 12, 13

Phelps v. Wyeth (D. Or. 2012) 857 F.Supp.2d 1114 ................................................................. 37

PLIVA, Inc. v. Mensing (2011) 564 U.S. 604 ........................................................................ 4, 14, 21, 22

Professional Engineers in California Gov’t v. Kempton (2007) 40 Cal.4th 1016 ................................................................................... 42

Randi W. v. Munroc Joint Unified School Dist. (1997) 14 Cal.4th 1066 ....................................................................... 3, 4, 5, 11

Schrock v. Wyeth, Inc. (10th Cir. 2013) 727 F.3d 1273 ................................................................ 36, 38

Sharp v. Leichus (Fla. Cir. Ct. Feb. 17, 2006, No. 2004-CA-0643) 2006 WL 515532 .............. 40 Sheeks v. American Home Products Corp.

(Dist. Ct. Colo. Oct. 15, 2004, No. 02CV337) 2004 WL 4056060 ................. 37 Short v. Eli Lilly & Co.

(Ind. Sup. Ct. Mar 25, 2009, No. 49D12-0601-CT-2187) 2009 WL 9867531 ............................................................................... 36, 37, 39 Sindell v. Abbott Laboratories

(1980) 26 Cal.3d 588 ................................................................................... 9, 10

Smith v. Wyeth, Inc. (6th Cir. 2011) 657 F.3d 420 .......................................................................... 38

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Stanley v. Wyeth (La. Ct. App. 2008) 991 So.2d 31 ............................................................. 37, 39

State Department of State Hospitals v. Superior Court (2015) 61 Cal.4th 339 ..................................................................................... 15

Strayhorn v. Wyeth Pharmaceuticals, Inc. (6th Cir. 2013) 737 F.3d 378 .............................................................. 23, 38, 41

Tsavaris v. Pfizer, Inc. (S.D. Fla. 2016) 154 F.Supp.3d 1327 ............................................................. 40

Washington v. Medicis Pharmaceuticals Corp. (S.D. Miss. Feb. 7, 2013, No. 3:12cv126) 2013 WL 496063 .......................... 37

Wyeth v. Levine (2009) 555 U.S. 555 ................................................................................. passim

Wyeth, Inc. v. Weeks, (Ala. 2014) 159 So.3d 649 ................................................................ 7, 8, 15, 41

Statutes

21 C.F.R. § 201.80(e) .......................................................................................... 26

21 C.F.R. § 310.70(c) .......................................................................................... 21

21 C.F.R. § 314.105(b) ........................................................................................ 43

21 C.F.R. § 314.70 .................................................................................. 21, 44, 49

21 C.F.R. § 10.25 ................................................................................................ 22

21 C.F.R. § 10.30 ................................................................................................ 22

21 C.F.R. § 10.33 ................................................................................................ 22

21 U.S.C. § 355 (1988) ................................................................................. 29, 43

35 U.S.C. § 154 ................................................................................................... 29

35 U.S.C. § 156 ................................................................................................... 29

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Civ. Code, § 1431.2 ............................................................................................. 55

Civ. Code, § 1714 ................................................................................................ 16

Code Civ. Proc., § 340.4 ..................................................................................... 58

Code Civ. Proc., § 998. ....................................................................................... 56

Code Civ. Proc., § 1032. ..................................................................................... 56

Code Civ. Proc., § 1033.5. .................................................................................. 56

Regulations

78 Fed. Reg. 67,985 ............................................................................................ 22

Other Authorities

Allen Rostron, Prescription for Fairness: A New Approach to Tort Liability of Brand-Name and Generic Drug Manufacturers,

(2011) 60 Duke L. J. 1123 ....................................................................... passim David A. Kessler & David C. Vladeck, A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims,

(2008) 96 Geo. L. J. 461 .................................................................................. 20 David G. Owen, The Evolution of Products Liability Law (2007) 21 Rev. Litig. 955 .................................................................................. 6

FDA Response to Citizen Petition on Terbutaline Doc. No. FDA-P-0358 (Feb. 17, 2011) ............................................................ 23

Restatement (Second) of Torts, Section 310 ....................................................... 2

Restatement (Second) of Torts, Section 311 ........................................... 1, 2, 3, 6

Restatement (Third) of Torts, Section 2 ............................................................. 2

Restatement (Third) of Torts, Section 9 ............................................................. 2

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Steven Garber, Rand Institute for Civil Justice, Economic Effects of Product Liability and Other Litigation Involving the Safety and Effectiveness of Pharmaceuticals (2013) ................................................ 32 U.S. Government Accountability Office (Dec. 2015) FDA Expedites Many Applications, But Data for Postapproval Oversight Need

Improvement ................................................................................................... 20

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ARGUMENT

Novartis’s amici argue, predictably, that allowing brand-

name manufacturers to be held liable for injuries caused by

generic drugs would up-end California tort law and wreak havoc

on the drug industry. None of amici’s arguments withstands

scrutiny.

I. Brand-Name Liability Is Entirely Consistent with California Tort Law. A. Novartis Can Be Held Liable Even Though It

Did Not Manufacture the Drug That Injured Plaintiffs.

Amici’s principle legal argument is that Novartis can’t be

held liable because it didn’t make the actual drug that injured

Plaintiffs, a fact that would be fatal to Plaintiffs’ claims under the

law of strict products liability.

This argument fails on multiple levels.

1. Plaintiffs Seek Recovery for Negligent Misrepresentation Under Section 311 of the Restatement of Torts.

First, this is not a product-liability case, and the

wrongdoing at issue does not concern the actual product that

injured Plaintiffs. Rather, Plaintiffs seek recovery for Novartis’s

negligent misrepresentation of the risks of its own product, a

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claim under Section 311 of the Restatement (Second) of Torts.

And it has long been recognized that a negligent-

misrepresentation claim involving physical injuries caused by a

product is distinct from a products-liability claim. (See Hanberry

v. Hearst Corp. (1969) 276 Cal.App.2d 680, 688–689 [recognizing

negligent-misrepresentation claim based on reliance on

“commercial endorsement” of product, but rejecting claim based

strict liability in tort, because defendant had not manufactured

product].)1

This distinction is underscored by the Restatement (Third)

of Torts, which recognizes misrepresentation claims as entirely

separate from product-liability claims. Section 9 of the

Restatement provides that “separate causes of action set forth in

the Restatement (Second) of Torts, governing liability for

fraudulent and negligent misrepresentation, are contained in §§

310 and 311. Case law has followed these Sections.” (Id.) It goes

on to state that “[a]lthough these Sections do not explicitly apply

1 (See also Brief of Consumer Attorneys of California and

American Assn. for Justice, pp. 15–19 [explaining origins of tort of negligent misrepresentation claim].)

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to commercial product sellers, they admit of such application.”

(Ibid., emphasis added.)

Along similar lines, Section 2 of the Restatement (Third) of

Torts, which defines the three categories of strict products

liability, provides:

Plaintiffs may … join claims based on product defect … and claims based on theories of recovery that do not rest on a premise of product defect at time of sale. Claims based on misrepresentation, express warranty, and implied warranty of fitness for particular purpose, in particular, are not within the scope of this Chapter and thus are unaffected by it.

(Rest.3d Torts, Product Liability, § 2, com. O, emphasis added.)

Thus, the “black letter of the Restatement [Third of Torts]”

is not “incompatible with innovator liability.” (Brief of Product

Liability Advisory Council (“PLAC”), p. 16). In reality, the

misrepresentation claims are “unaffected” by, and coextensive

with, the chapter governing product liability. (Id.)

2. Negligent Misrepresentation Claims Are Not Subject to an Instrumentality Requirement.

Second, unlike product-liability claims, a claim for

negligent misrepresentation under Section 311 has no

“instrumentality” or “product-identification” requirement.

Section 311 provides:

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One who negligently gives false information to another is subject to liability for physical harm caused by action taken by the other in reasonable reliance upon such information, where such harm results (a) to the other, or (b) to such third persons as the actor should expect to be put in peril by the action taken.

None of this Court’s cases adopting Section 311 suggests

that it should be limited to cases where the defendant

manufactured or controlled the “instrumentality” that injured the

plaintiff otherwise. (See Randi W. v. Munroc Joint Unified

School Dist. (1997) 14 Cal.4th 1066, 1077 [holding that a school

district’s misrepresentations about a former employee in a letter

of recommendation could render district liable under Section 311

for employee’s molestation of student at his new school]; Garcia v.

Superior Court (1990) 50 Cal.3d 728, 735–736 [holding that

parole officer’s misrepresentations to parolee’s prior victim

resulting in her death could be basis for liability under Section

311].)

The U.S. Chamber of Commerce (the “Chamber”) attempts

to distinguish Garcia and Randi W. on the ground that, in both

cases, “the defendants had made representations about the future

conduct of specific individuals, and those same individuals later

injured others”—arguing that, unlike here, “[t]hose individuals …

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provided the very ‘instrumentality’ required under the general

principles of tort law to link the alleged wrongdoers’

misrepresentations to the plaintiffs’ harm.” (Chamber Br., p. 5.)

But unlike Garcia and Randi W., where the

“instrumentalities” that harmed the plaintiffs were individuals

over whom the defendants had no formal relationships and

exerted no control, Plaintiffs seek to hold Novartis liable for

misrepresenting the risks of a drug that was pharmalogically

identical to the “instrumentality” that ultimately injured them.

(See 21 U.S.C. § 355(j)(2)(A)). And because federal law requires

generic manufacturers to use the same warnings as the brand-

name equivalent (see PLIVA, Inc. v. Mensing (2011) 564 U.S. 604,

613), Novartis could easily foresee that its inadequate labeling

would be relied on by doctors when prescribing Brethine to

patients whose prescriptions might ultimately be filled with

generic Brethine. Thus the link between Novartis’

misrepresentations and Plaintiffs’ injuries was actually more

direct and foreseeable than in either Randi W. or Garcia.2

2 (See Allen Rostron, Prescription for Fairness: A New

Approach to Tort Liability of Brand-Name and Generic Drug Manufacturers (2011) 60 Duke L. J. 1123, 1174 [“If a brand-name drug manufacturer is negligent in designing its product or in

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It would be no more justifiable to excuse Novartis for

disseminating false information about Brethine simply because it

didn’t make the tablets that injured Plaintiffs, than it would be to

conclude that Plaintiffs’ mother’s physician owed her no duty of

care simply because he didn’t make the tablets she ingested. In

both cases, the defendant’s duty toward the Plaintiffs arises

independent of the manufacture or sale of the tablets, and the

defendant’s breach of the duty leads proximately to the Plaintiffs’

injury, regardless of who manufactured the terbutaline she took.

3. Negligent-Misrepresentation Claims Are Not “Substantively Indistinguishable” from Product-Liability Claims.

Amici nonetheless insist that negligent-misrepresentation

claims should be subject to an instrumentality requirement

because they are “substantively indistinguishable” from product-

liability claims. (See PLAC App., p. 3.) Not so.

preparing labeling …, it is highly foreseeable that the risk created will extend to those taking the generic substitutes …. And given that brand-name manufacturers effectively dictate crucial aspects of the generic products’ designs and the contents of their labeling, the brand-name manufacturers’ insistence that they have no control over generic drugs is like a person saying that he has no control over his own shadow.”].)

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This argument fails, first, because even if Plaintiffs’

negligent-misrepresentation claim were “substantively

indistinguishable” from a product-liability claim (and it is not—

see below), allowing that fact to categorically preclude claims for

product-caused injuries from being brought under Section 311

would turn the law of product liability against the very

constituency it was designed to help.

The doctrine of strict product liability, first adopted in

Greenman v. Yuba Power Prods. (1963) 59 Cal. 2d 57, 63, was

intended to assist consumers and advance overall social goals by

eliminating the need to prove fault in cases involving defective

products. (Ibid.; see generally David G. Owen, The Evolution of

Products Liability Law (2007) 21 Rev. Litig. 955, 966–974.) But

Novartis and its amici seek to use the doctrine of strict liability

as a sword against injury victims, arguing that product-liability

claims were intended to displace all other available remedies,

even where the plaintiffs can prove the defendant was negligent

and would otherwise be left without any remedy. That cannot be

how the law was intended to apply.

That aside, amici’s argument that there is no real

difference between negligent-misrepresentation claims and strict-

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liability claims—and, as a result, that the former should be

subject to the same “instrumentality” requirement as the latter—

is wrong on its own terms, as the Alabama Supreme Court held

in Wyeth, Inc. v. Weeks (Ala. 2014) 159 So.3d 649.)

There, as here, the brand-name manufacturer argued that

because the plaintiff’s negligent-misrepresentation claim alleged

physical injuries caused by a product, “the plaintiff must prove

that the defendant manufactured the product the plaintiff claims

injured him.” (Id. at p. 656.) In rejecting this argument, Weeks

explained that negligent misrepresentation “is not a claim that

the drug ingested by [plaintiff] was defective; instead, it is a

claim that Wyeth fraudulently misrepresented or suppressed

information about the manner in which (i.e., the duration) the

drug was to be taken.” (Id. at p. 658.) And, because the

plaintiff’s claim was based “on what Wyeth said or did not say

about Reglan and their assertion that those statements or

omissions caused [plaintiff’s] injuries ...,” there was no basis for

concluding that the misrepresentation claim “[was] in substance

a products-liability claim.” (Id. at p. 658.)3

3 (See also Huck v. Wyeth, Inc., 850 N.W.2d 353, 385-389

(Iowa 2014) (conc. & dis. opn. of Hecht, Wiggins, and Appel, JJ.)

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The flawed attempt to equate negligent-misrepresentation

claims with strict-liability claims was one of the central errors in

Foster v. American Home Products, Inc., 29 F.3d 165 (4th Cir.

1994), the ruling underlying the “mountain” of authority cited by

amici. (See Prescription for Fairness, supra, 60 Duke L. J. at p.

1164.)

Weeks criticized Foster on this point, concluding that,

“[b]ecause a warning label is not a part of the manufacturing

process, we do not agree that the fact that a brand-name

manufacturer did not produce the version of the drug ingested by

the plaintiff bars the plaintiff’s tort action [based on] failure to

warn.” (Weeks, 159 So.3d at p. 670.)

Foster and its progeny all make the same basic error: they

fail to understand that where, as here, a brand-name

manufacturer is being sued for negligently misrepresenting the

defects of its own product, the fact that it did not make the

product that injured the plaintiff is irrelevant to the underlying

cause of action. The question, rather, is whether the

[disagreeing with majority’s imposition of instrumentality requirement and collecting cases rejecting same in product-liability context.])

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manufacturer’s wrongdoing with respect to its own product is the

proximate cause of the plaintiff’s injuries.

The policies underlying strict products liability make clear

why the defendant’s liability in such cases is tied to its status as

the supplier or manufacturer of the injury-causing product. As

reaffirmed in O’Neil v. Crane Co. (2012) 53 Cal.4th 335, the core

rationale behind strict product liability “is to insure that the costs

of injuries resulting from defective products are borne by the

manufacturers that put such products on the market rather than

by the injured persons who are powerless to protect themselves.”

(Id., emphasis added.)

It thus makes sense that strict-liability claims can only be

brought against the manufacturer of the product that caused the

injury—that is the only way to achieve the cost-spreading goal

behind strict liability. In contrast, in the context of a negligent-

misrepresentation claim, the need to establish fault by the

defendant obviates the need to strictly limit liability to those who

made or sold the offending product. (See, e.g., Hanberry, supra,

276 Cal.App.2d at p. 686.)

Put another way, the reason for the instrumentality

requirement in the strict-liability context—to ensure that the cost

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of injuries are borne by the offending product’s manufacturer—is

simply not present in the negligence context, where the

overriding consideration is not one of social cost spreading but

rather determination of fault.

4. Amici’s “Instrumentality” Case Law Does Not Help Its Cause.

Amici’s main instrumentality case is Sindell v. Abbott

Laboratories (1980) 26 Cal.3d 588, 597, which they cite for the

proposition that, as a “general rule, the imposition of liability

depends upon a showing that the plaintiff that his or her injuries

were caused by the act of the defendant or by an instrumentality

under the defendant’s control.” (See U.S. Chamber of Commerce

Br., p. 3, emphasis added.) As the bolded word in that sentence

reveals, Sindell permits liability where the plaintiffs’ injuries

were caused by “[an] act of the defendant.” (Id.) And in this case,

Plaintiffs allege that their injuries are caused by “an act of the

defendant”—specifically, Novartis’s act of negligently

misrepresenting the serious risks of its product to the developing

fetal brain.

Where amici go wrong is by confusing negligent design-

defect claims (which were alleged in Sindell) with negligent-

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misrepresentation claims (which are alleged here). When it

comes to the former, it makes sense to require that the defendant

have made the injury-causing product, because the wrongdoing is

inseparable from the “instrumentality.” Again, the focus is on the

product, not the defendant’s conduct.

But in negligent-misrepresentation cases, the inquiry is

whether the defendant misrepresented the facts and, if so,

whether those misrepresentations presented a foreseeable risk of

harm to a third party. The fact that, here, the “instrumentality”

that injured Plaintiffs was another manufacturer’s product does

nothing to lessen the extent of Novartis’s wrongdoing.

Amici’s reliance on Merrill v. Navegar (2001) 26 Cal.4th

465, is equally misplaced. (See PLAC Br., p. 20.) Merrill held

that a statute prohibiting “product-liability” claims against gun

manufacturers barred the plaintiffs’ negligence claim because the

“allegations squarely fit within the risk/utility test for defective

design that applies in a products liability action under both

negligence and strict liability theories.” (Id. at p. 481.) Properly

understood, Merrill merely stands for the proposition that a

statutory reference to “product liability” should be read broadly

where doing so was necessary to effectuate the statute’s manifest

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purpose. (E.g., id. at p. 493 (conc. opn. of Kennard, J. [“The task

of the judiciary is to interpret those statutes by ascertaining and

effectuating the Legislature’s intent. It is not for us to question

the wisdom of the Legislature’s considered judgments.”].)

Kesner v. Superior Court (2016) 1 Cal. 5th 1132, does not

further amici’s cause either. Amici argue that Kesner supports

their “instrumentality” theory because, there, the asbestos fibers

that employees carried home from their workplace constituted

“an instrumentality linking the defendant’s alleged negligence

with the plaintiffs’ harm.” (See Chamber Br., pp. 3–4, fn. 1.)

This argument improperly assumes that there must be

some sort of physical “instrumentality” (such as asbestos fibers)

linking a defendant’s negligence and the plaintiffs’ injuries. This

Court has never held such a thing—neither Garcia nor Randi W.

involved any kind of “physical instrumentality” linking the

defendant and the plaintiff—and such a rule would make no

sense in a negligent-misrepresentation case, where the very

essence of the claim is informational in nature.

That aside, amici fail to recognize that, if anything, this is a

far more persuasive case for recognition of a tort duty than

Kesner. There, the predominant focus was the foreseeability of

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the hazard (i.e., secondary exposure from asbestos fibers).

(Kesner, supra, 1 Cal.5th at pp. 1145–1149.) But because, under

the federal scheme, all warnings associated with a drug—brand-

name or generic—are dictated by the brand-name manufacturer,

the fact that consumers of generic drugs will rely on warnings

issued by a brand-name manufacturer is at least as foreseeable

as the secondary exposure this Court deemed foreseeable in

Kesner.

And while the defendants’ control over airborne asbestos

fibers was a factor in Kesner, the control that brand-name

manufacturers exert over any warnings associated with any form

of their drug is at least as strong as the degree of control that

landowners and employers have over stray asbestos fibers

clinging to their employees’ and visitors’ clothing.

Stripped of these cases, all that amici are left with is O’Neil

v. Crane Co (2012) 53 Cal.4th 553, which they argue established

an instrumentality requirement for both strict-liability and

negligence claims. Because O’Neil is addressed at length in

Plaintiffs’ Answer Brief (at pp. 28–36), Plaintiffs merely

reemphasize one key point:

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O’Neil helps Plaintiffs, not Novartis, because it reaffirmed

the distinction between strict-liability and negligence claims. As

to the former, O’Neil held that “a product manufacturer generally

may not be held strictly liable for harm caused by another

manufacturer’s product.” (Id. at p. 362, emphasis added.) But as

to the latter, O’Neil applied the Rowland factors to determine

whether to create an exception to the general duty of care under

California law (id. at pp. 364–366), just as the Court of Appeal

did in Conte and the decision below, and just as Plaintiffs ask the

Court to do here.

If, as amici contend, O’Neil intended to categorically

preclude negligence claims for product-caused injuries against

defendants who did not make the injury-causing product, then

why did O’Neil bother with a Rowland4 analysis of the plaintiffs’

negligence claim? Amici have no answer to that question, which

is not surprising, for there is none.

5. Amici’s Policy Arguments in Support of their “Instrumentality” Theory Lack Merit.

Amici insist that affirming the lower court’s decision would

result in an unprecedented “slippery slope” of tort liability by

4 (See Rowland v. Christian (1968) 69 Cal.2d 108, 112.)

- 16 -

allowing plaintiffs to sue companies for injuries caused by

products they didn’t make—including generically identical

products (e.g., chlorine bleach), high-tech products, and

counterfeit goods. (E.g., PLAC Br. at p. 24.)

This argument overlooks a crucial distinction between

ordinary consumer goods and pharmaceutical drugs that

undermines amici’s “slippery slope” argument: Makers of

ordinary consumer goods have sole discretion regarding the

content of their own warning labels. In contrast, brand-name

prescription drug manufacturers dictate the content of all

warnings associated with that drug, whether brand-name or

generic. (See Mensing, supra, 564 U.S. at p. 613.)

This matters because, in any case involving allegedly

inadequate product warnings, the law presumes the plaintiff

would have escaped injury if an adequate warning appeared on

the product the plaintiff actually used. (See, e.g., Johnson v.

American Standard, Inc. (2008) 43 Cal.4th 56, 65.)

And because, in the context of ordinary consumer goods,

the absence of an adequate warning on the product the plaintiff

actually used was solely the fault of the manufacturer of that

product, the causal nexus between the plaintiff’s injuries and

- 17 -

warnings issued by another company is inherently—if not

fatally—attenuated.

But because the absence of adequate warnings on any

generic drug label is the direct result of choices made by the

brand-name manufacturer of that drug, the causal chain between

the brand-name manufacturer’s negligence in crafting those

warnings and the plaintiff’s resulting injury is inherently direct.

This distinction makes all the difference from a causal

perspective. (E.g., State Department of State Hospitals v. Superior

Court (2015) 61 Cal.4th 339, 356 [holding that causal chain

between negligent omission and injury severed where occurrence

of injuries depended on independent, discretionary acts of third

parties].) Thus, existing tort rules would prevent amici’s

doomsday “slippery slope” of tort liability without the need to

impose new and artificial limits on the tort of negligent

misrepresentation.

* * *

In short, amici’s attempt to derail this case by importing an

“instrumentality” requirement from the law of products liability

fails on all fronts. This case addresses whether brand-name

manufacturers should be held liable for violation their own duty

- 18 -

of care with regard to their own products—specifically, their duty

to update their labels to warn of serious risks that only become

known during the post-market period, a duty that already exists

under federal law. So long as Novartis’s misconduct played a

causal role in Plaintiffs’ injuries—which Plaintiffs seek to prove

in this lawsuit—the fact that Novartis did not manufacture the

tablets that injured Plaintiffs is, as the Alabama Supreme Court

found, irrelevant. (Weeks, supra, 159 So.2d at p. 658.)

B. The Rowland Factors Counsel in Favor of Recognizing a Duty of Care in this Case. The only serious question in this case is whether Plaintiffs’

negligent-misrepresentation claim satisfies the test set forth in

Rowland, supra, 69 Cal.2d at p. 112. Contrary to what amici

imply, this Court relies on the Rowland factors “not to determine

whether a new duty should be created, but whether an exception

to Civil Code section 1714 … should be created.” (Ibid., emphasis

added, citation omitted.) And, crucially, this Court “will not

carv[e] out an entire category of cases from th[e] general duty

rule” of section 1714, subdivision (a), unless doing so “is justified

by clear considerations of policy.” (Ibid., quoting Cabral v. Ralphs

- 19 -

Grocery Co. (2011) 51 Cal. 4th 764, 772, emphasis added.) Amici

have not made that showing here.

1. Amici’s “Foreseeability” Arguments Lack Merit.

Foreseeability is not seriously disputed in this case. For all

the reasons previously explained (see ABOM, pp. 37–38), it is not

merely “foreseeable” to a brand-name manufacturer that its

misinformation will mislead consumers of generic drugs as easily

as consumers of brand-name drugs, it is a virtual certainty. (See

also Prescription for Fairness, supra, 60 Duke L. J. at pp. 1165–

1166.)

Tellingly, amici don’t even attempt to deny foreseeability as

a factual matter. Instead, they argue that “mere foreseeability”

is not the proper legal test for imposition of a tort duty under

California law. (See Brief of Civil Justice Association of

California (“CJAC”), p. 11 [arguing that Plaintiffs “equat[e]

foreseeability with duty under negligence law…despite this

Court’s sound authority to the contrary,” emphasis in original,

citations omitted.)

But Plaintiffs have never argued that foreseeability is the

only factor relevant to the duty analysis under California law. To

the contrary, Plaintiffs have argued that the test to determine

- 20 -

whether an exception to the general duty of care is warranted is

the multi-factor test set forth in Rowland, supra, 69 Cal.2d at p.

113, which includes, but is not limited to, factors related to

foreseeability. (ABOM, pp. 37–47.) And, indeed, Plaintiffs went

on to explain why all of the Rowland factors are met in this case,

including foreseeability. (Ibid.)

It is in fact amici who treat foreseeability inappropriately

by arguing that “‘foreseeability’ is an elusive, open-ended

touchstone” and therefore that “as a factor for ascertaining duty,

‘foreseeability’ offers little guidance.” (E.g., Civil Justice

Association of California (CJAC), p. 10.) But that sentiment

directly contradicts this Court’s unequivocal admonition that

“foreseeability [i]s the predominant factor in duty analysis.”

(Kesner, supra, 1 Cal.5th at p. 1163; see also id. at p. 1132

[holding that foreseeability is “[t]he most important factor to

consider in determining whether to create an exception to the

general duty to exercise ordinary care….”].)5

5 Amici also rely heavily on In re Darvocet (6th Cir. 2014)

756 F.3d 917, 944, for the proposition that the lower court’s approach somehow “stretches foreseeability too far.” But in so ruling, the Sixth Circuit improperly conflated foreseeability with a policy conclusion that it is somehow not “fair” to hold brand-name manufacturers liable for injuries caused by generic drugs

- 21 -

2. Amici’s Public Policy Arguments Do Not Justify a Categorical Exception to the Duty of Care.

The only remaining question under Rowland is whether

there is any “clearly” compelling policy reason to create an

exception to the duty of care. Amici have provided none.

a. Prevention of Future Harm.

Amici don’t dispute the serious health risks posed by

inadequately labeled generic drugs. Nor do they dispute that

serious hazards often emerge long after a drug has been

approved. That is not surprising, since there are myriad real-

world examples of serious drug risks becoming known only after

a drug has “gone generic.” (See Brief of Public Citizen, pp. 2–3;

Prescription for Fairness, supra, 60 Duke L.J. at p. 1191 [citing

examples in support of the observation that “drug companies

have also been responsible for some of the world’s most notorious

product catastrophes”].)

based on federal drug laws “over which the brand manufacturers have no control.” (Id.) Not only was that approach to foreseeability legally erroneous, but the Court’s policy conclusion—which appears to have been based on a single law review article written by advocates for the drug industry (see id. at p. 945)—it is also indefensible, for all the reasons explained below.

- 22 -

Instead, amici argue that it is not necessary to impose tort

liability on brand-name manufacturers to protect the public from

inadequately labeled drugs. Amici advance several arguments in

support of that premise, none of which persuade.

First, amici argue that the FDA’s regulations already

provide sufficient incentives to drug manufacturers to update

their labels without tort liability. (E.g., Brief of Pharmaceutical

Researchers and Manufacturers of America (“PHARMA”), p. 21.)

This argument ignores the U.S. Supreme Court’s holding

that “state tort suits” are critical to maintaining American

citizens’ access to safe drugs because they “uncover unknown

drug hazards and provide incentives for drug manufacturers to

disclose safety risks promptly.” (Wyeth v. Levine (2009) 555 U.S.

555, 579.) As the Court observed, tort suits “serve a distinct

compensatory function that may motivate injured persons to

come forward with information.” (Ibid.) Thus, Wyeth concluded,

“state law offers an additional, and important, layer of consumer

protection that complements FDA regulation.” (Ibid.)

Relatedly, amici’s argument depends on the premise that

the FDA can adequately police drug labels by monitoring

postmarketing safety data and, where necessary, bringing

- 23 -

“misbranding” actions against drug manufacturers who fail to

keep their labels up to date. But that premise is pure fiction.

The FDA’s inability adequately to monitor postmarketing

safety data has been a subject of intense concern for over a

decade (see David A. Kessler & David C. Vladeck (2008) 96 Geo.

L. J. 461, 485, A Critical Examination of the FDA’s Efforts to

Preempt Failure-to-Warn Claims, [“A Critical Examination”]),

and it is still a serious concern today. As recently as December

2015, for example, a U.S. Government Accounting Office report

concluded that, for a variety of reasons, a “the FDA’s ability to

conduct systematic oversight of postmarket safety” is

“restrict[ed].”6

Amici’s argument that brand-name manufacturers could be

induced to update their labels in order to avoid FDA

“misbranding actions” is just as fanciful. As one former FDA

Commissioner has explained, “the FDA has rarely, if ever,

brought a misbranding action against the manufacturer of an

6 (See U.S. Government Accountability Office, FDA

Expedites Many Applications, But Data for Postapproval Oversight Need Improvement (Dec. 2015), at p. 26 <http://www.gao.gov/assets/680/674183.pdf> [as of Feb. 15, 2017].)

- 24 -

approved drug being promoted only for approved uses.” (A

Critical Examination, supra, at p. 479, fn. 80, emphasis added.)7

Amici’s argument that brand-name-manufacturer liability

is not necessary because generic drug manufacturers have the

means to effectuate a label change is just as flawed. In so

arguing, amici drastically overstate the ability of generic-drug

manufacturers to update their labels in a timely fashion. Unlike

brand-name manufacturers, which can unilaterally add warnings

under the FDA’s “changes-being-effected” regulation (21 C.F.R. §

310.70(c)), the only thing a generic drug company can do is ask

the FDA for permission to add or strengthen the warnings in its

labeling. (See 21 C.F.R. § 314.70.) This may sound adequate in

theory, but it is manifestly inadequate in practice.

That premise is implicit in the U.S. Supreme Court’s

holding that it would be “impossible” for generic drug

manufacturers to meet state tort duties to update drug labeling

without violating federal regulations that require generics to use

7 “Misbranding” actions are typically brought against companies selling unapproved drugs or approved drugs being markets for unapproved uses. (See id.) Research has uncovered no misbranding actions by the FDA against brand-name drug companies based on a company’s failure to update its label to disclose a postmarket risk, and amici have cited none.

- 25 -

the same labels as brand-name manufacturers. (Mensing, supra,

564 U.S. 604.) If requesting a label change from the FDA were

an efficient and effective method for generic-drug manufacturers

to update drug labeling, then it would not have been “impossible”

for them to simultaneously satisfy their obligations under both

state and federal law. (Id.)

And whatever motive generic manufacturers might have

had to police their labels and request label changes before the

U.S. Supreme Court’s preemption ruling in Mensing would have

vaporized now that generic drug manufacturers cannot be sued

for failing to warn of newly discovered risks. As the FDA itself

recently observed in the preamble to a proposed rule that, if

enacted, would give generic manufacturers the right to

unilaterally change their labels to disclose newly discovered

risks, the immunity from suit under Mensing has greatly

“alter[ed] the incentives for generic drug manufacturers to

comply with current requirements to conduct robust

postmarketing surveillance, evaluation, and reporting, and to

- 26 -

ensure that the labeling for their drugs is accurate and up to

date.” (78 Fed. Reg. 67,985, 67,988–67,989.)8

But even generic manufacturers who do take their duties

seriously and request a label change are likely to receive a slow

response from the FDA. The ability to request a labeling change

is, as a practical matter, no different than the ability of an

ordinary citizen to file a “Citizen’s Petition” seeking a revision to

a drug’s label. (See 21 C.F.R. §§ 10.25, 10.30, 10.33.) But

because, as noted above, the FDA simply does not have the

resources to monitor the many drugs on the market in a timely

fashion, it lacks the ability to timely respond to requests for label

changes. (See Wyeth, supra, 555 U.S. at pp. 578–579 [“The FDA

has limited resources to monitor the 11,000 drugs on the

market…”]; see generally Public Citizen Br. at pp. 2-6 [describing

limitations on generic drug manufacturers’ ability to update

labels].)

Using this case as an example, it took the FDA three years

to respond to a 2008 citizen’s petition calling for stronger

8 That amendment has been repeatedly delayed as a result

of drug industry lobbying and may never become law. (See ABOM, p. 10, fn. 2.)

- 27 -

warnings on the Brethine label regarding risks to fetal health.9

There is no telling how many children suffered severe cognitive

defects from Brethine exposure during that period.

The FDA’s limited resources and resulting inability to

quickly react to label deficiencies is why the federal scheme gives

brand-name manufacturers both the obligation and the means to

immediately implement additional warnings when the need

arises. By vesting brand-name manufacturers with the proactive

ability to unilaterally add warnings to drug labeling while giving

generic manufacturers only the passive ability to request a label

change, it is clear that Congress intended brand-name drug

manufacturers to be the primary guardians of warning-label

accuracy. (See, e.g., Strayhorn v. Wyeth Pharmaceuticals, Inc.

(6th Cir. 2013) 737 F.3d 378, 410 (conc. & dis. opn. of Stranch,

J.).) A rule that would significantly diminish the motivation of

brand-name manufacturers to quickly implement label changes

would thus undercut the primary mechanism for ensuring

9 (See FDA Response to Citizen Petition on Terbutaline,

Doc. No. FDA-P-0358 (Feb. 17, 2011) <http://www.fda.gov/downloads/Drugs/DrugSafety/ UCM243797.pdf> [as of Feb. 15, 2017].)

- 28 -

adequate drug labeling, in direct contradiction of Congress’s

intent.

Amici’s fallback argument is that imposition of tort liability

for injuries caused by generic drugs would backfire, by causing

brand-name manufacturers to withdraw their NDAs and leave

the marketplace. This argument, too, fails on several levels.

First, as Public Citizen points out, “no evidence supports

the speculation that a rule allowing brand-name manufacturers

to be held liable for injuries caused by generic versions of their

products would cause brand-name manufacturers to change their

behavior.” (Public Citizen Br., p. 11.)

And for good reason: For one, under the lower court’s

approach, NDA withdrawal would not relieve a manufacturer of

liability for its past misconduct, if (as in this case) the label was

inadequate at the time the manufacturer withdrew the NDA and

the injured patient’s reliance on the label was foreseeable.

Indeed, the specter that brand-name manufacturers might seek

to evade liability for mislabeled drugs by fleeing the market is yet

another reason to impose liability on even former brand-name

manufacturers, not a reason to grant brand-name manufacturers

blanket immunity.

- 29 -

That aside, the fact that brand-name manufacturers might

withdraw their NDAs when faced with tort liability for injuries

caused by generic drugs is not a reason to categorically foreclose

the imposition of such liability. Brand-name manufacturers’

responsibility to update their labels while they still own the NDA

“does patients little good if those manufacturers have no

responsibility for failing to fulfill that responsibility.” (Public

Citizen Br., p. 11.) And without a rule imposing liability on

brand-name manufacturers who negligently fail to update drug

labels while they still control them, brand-name manufacturers

will have little incentive to update the labels once their patent

expires and generics enter the market.

In short, “Novartis’s plea to be exempt from accountability

for labeling for which it is solely responsible for exacerbates a

dangerous safety gap.” (Id. at p. 10.) Brand-name

manufacturers play a key role in terms of ensuring the safety of

drug labels, both for their own drugs and for their generic

counterparts. Tort liability, in turn, helps ensure that they take

this job seriously. Granting them the immunity they seek here

would reward wrongdoing at the expense of public safety.

- 30 -

b. Burden on the Defendant.

In Kesner, this Court reaffirmed that “the relevant burden

in the analysis of duty is not the cost to the defendants of

compensating individuals for past negligence,” but “the cost to

the defendants of upholding, not violating, the duty of care.”

(Kesner, supra, 1 Cal.5th at p. 1152.)

With that in mind, the imposition of tort liability on brand-

name manufacturers for injuries caused by generic drugs is

“burdenless” insofar as it would require things—closely

monitoring scientific data for hazards associated with their drugs

and immediately adding warnings to address those hazards—

that brand-name manufacturers are already required to do under

federal law. (See 21 C.F.R. § 201.80(e).)

Absent a burden to bemoan, amici default to the complaint

that it simply isn’t “fair” to ask brand-name manufacturers to

pay the tort liability of their generic competitors.

This argument fails on several levels.

First, amici’s fairness argument incorrectly focuses

exclusively on the brand-name and generic manufacturers,

without any concern for the innocent victims who were harmed

by a dangerously mislabeled drug.

- 31 -

But any “unfairness” of holding brand-name drug

manufacturers liable to customers who purchased a generic

product is dwarfed by the unfairness of denying compensation to

the millions of future victims of mislabeled drugs for often serious

injuries because of the chance fact that the customers’

prescription was filed with a generic equivalent of the drug they

were prescribed. This unfairness grows exponentially when one

remembers that the victims often had no say in the

determination to dispense them a generic version of the drug as

opposed to the brand-name version. (See Prescription for

Fairness, supra, 60 Duke L. J. at p. 1176.)

Second, amici’s fairness argument rests at least in part on

the premise that to hold brand-name manufacturers liable for

injuries caused by generic drugs would effectively treat a brand-

name manufacturer’s own customers the same as its competitors’

customers (i.e., consumers of generic drugs). But that is far from

true.

Under this Court’s decision in Carlin v. Superior Court

(1996) 13 Cal.4th 1104, consumers of a brand-name medication

can hold the corresponding manufacturer strictly liable for failing

to warn of risks that are “scientifically knowable” even if they

- 32 -

were not actually known to the drug manufacturer at the time it

manufactured the drug. (Id. at p. 1111.)

In contrast, if affirmed, the decision below would only

permit consumers of generic drugs to assert liability against

brand-name manufacturers who negligently fail to provide

accurate warning information regarding a hazard they actually

knew or reasonably should have known.

As such, from a “fairness” perspective, the decision below

reflects a principled compromise between, at one extreme, strict

liability for failing to disclose merely “knowable” risks of a

medication, and at the other extreme, foreclosing any

compensation to victims merely because, likely unbeknowst to

them, their prescription were filled with a generic rather than a

brand-name version of the drug.

Third, it cannot be overemphasized that liability in this

case will depend on proof that Novartis negligently disseminated

inaccurate information regarding serious risks of its own drug

product, and did so despite the knowledge that every consumer of

that drug product—brand-name or generic—would depend on the

accuracy of that information in choosing whether or not to use

the drug. Indeed, the false premise in amici’s fairness argument

- 33 -

is that brand-name manufacturers will be forced to pay for the

liability of their generic competitors. But because brand-name

manufacturers dictate the contents of drug labeling, in a case

arising out of an inadequate label, the fault is theirs, not the

generic manufacturers’.

As this Court recently observed, California law maintains a

strong public policy “aimed at protecting consumers from the

potential dangers posed by prescription medication, including

warnings about serious side effects and prohibiting false and

misleading labeling” (Bristol–Meyers Squibb Co. v. Superior

Court (2016) 1 Cal.5th 783, 810.) Given that strong public policy,

there is nothing inherently “unfair” about requiring a brand-

name drug manufacturer “to shoulder its share of responsibility

for injuries shown to have been caused, at least in part, by its

dissemination of false information,” which it reasonably should

expect will be relied upon by consumers of that drug product,

brand-name or generic. (Conte, supra, 168 Cal.App.4th at pp.

109–110.)

Finally, amici’s fairness argument ignores the numerous

benefits that brand-name manufacturers were granted when

Congress decided to make it easier for generic drug

- 34 -

manufacturers to enter the marketplace. Under the Hatch–

Waxman Act, brand-name drug manufacturers are entitled to an

initial period of government-protected monopoly privileges in the

form of patent protection. (See 35 U.S.C. § 154.) They are also

entitled to an extension of those monopoly privileges when

generic versions of their drugs receive FDA approval (See id. §

156 [patent-term extension]; 21 U.S.C. § 355 [pairing generic

approval with patent-term extension].) In addition, they enjoy

“the fiscal rewards of name-brand recognition and the

commensurate ability to charge a higher price ..., even after

[their] exclusive marketing position expires.” (Conte, supra, 168

Cal.App.4th at p. 111.)

Ultimately, the allegedly “unfair” situation is the result of a

federal drug scheme created by Congress—a scheme that grants

considerable benefits to brand-name manufacturers, as well as

certain burdens. Amici ask this court to second-guess that

scheme—to declare it “unfair” and eliminate an entire category of

tort liability—in order to rectify the allegedly unjust treatment of

brand-name manufacturers. But as amici themselves repeatedly

have argued to this Court, the perceived “unfairness” of federal

drug law is not a sufficient basis to upset what Congress has

- 35 -

created. (E.g., Brief of Wash. Legal Foundation, p. 14; CJAC Br.,

p. 7.) Plaintiffs wholeheartedly agree.

c. Consequences to the Community.

In terms of “consequences to the community,” amici insist

that imposition of liability on brand-name manufacturers would

devastate the brand-name drug industry by destroying

innovation and stimulating “over-warning,” ultimately harming

public health. (See, e.g., Chamber Br., pp. 20–29; PHARMA Br.,

pp. 10–17.)10

Amici offer no actual evidence that affirming the decision

below will lead to over-warning or stifle innovation. Instead, they

offer only self-serving conjecture, conjecture that is belied by the

fact that California law has imposed liability on negligent brand-

name manufacturers for injuries caused by generic drugs since

2008 and yet no apparent increase in over-warning or decrease in

drug innovation has occurred since that time.

Not coincidentally, amici’s over-warning argument was

already rejected by this Court in Carlin, supra, 13 Cal.4th at pp.

10 Amici also argue that, if affirmed, the lower court’s ruling

would result in skyrocketing brand-name drug prices. Because that argument is rebutted throughout AARP’s amicus brief, Plaintiffs do not address it here.

- 36 -

1353–1354, which allowed strict-liability claims against brand-

name drug manufacturers for failing to warn about risks that

were “scientifically knowable,” even if they were not actually

known by the manufacturer at the time of the plaintiff’s injury.

Ultimately, Carlin concluded that “there is no evidence that any

such [over-warning] problem has emerged …, despite the fact

that strict liability has long been the rule in California.” (Id. at p.

1354, fn. 6.)

That holding should control here. If, as Carlin held, the

imposition of strict liability for failure to warn of “scientifically

knowable” risks would not stimulate over-warning, then it is

exceedingly difficult to see how the imposition of mere negligent-

misrepresentation claims for risks a brand-name manufacturer

knows or should know about will suddenly inspire over-warning.

But even in the exceedingly unlikely event that it would, as

between the two alternatives—under-warning or over-warning—

the latter is certainly the lesser of two evils. Indeed, the FDA

retains the power to remove warnings it deems unnecessary.

(Wyeth, supra, 555 U.S. at p. 571 [“[T]he FDA retains authority to

reject labeling changes made pursuant to the CBE regulation in

its review of the manufacturer’s supplemental application.”].)

- 37 -

Given the FDA’s strained resources and resulting slow response

time, from the perspective of public safety, it makes more sense

to rely on the FDA to remove unnecessary warnings than to

supply necessary ones that are dangerously absent.

Carlin also rejected the argument tort liability would deter

innovation in the pharmaceutical industry. (See Carlin, supra,

13 Cal.4th at p. 1117.) In fact, this Court reached the opposite

conclusion, holding that because “[d]rug manufacturers need only

warn of risks that are actually known or reasonable scientifically

knowable ... requiring manufacturers to internalize the costs of

failing to determine such risks may instead increase the level of

research into safe and effective drugs.” (Id.)

Carlin’s holding should apply with even greater force in the

context of this case. If, as Carlin held, stifling innovation is not a

concern in the context of a strict-liability failure-to-warn case,

then surely those policy concerns should be accorded even less

weight in a negligent-misrepresentation case.11

Notably, the most recent evidence on the actual impact of

tort liability on the pharmaceutical industry refutes amici’s

11 Only one of Novartis’s amici even attempts to deal with Carlin (see PHARMA Br., p. 14, fn. 5); most ignore it completely.

- 38 -

apocalyptic predictions. A 2013 study from the RAND Institute

for Civil Justice attempted to evaluate the economic effects of

product liability litigation on the pharmaceutical industry.12 The

report concluded that “there is scant empirical evidence to

support the claims on either side of the debate, and the literature

provides little reliable information about common or typical

product liability.” (See Garber, Economic Effects, note 12, at p.

xiv.) Arguments about “over-warning,” the study stated, “are

controversial within the medical community, and there is no

direct evidence about it.” (Ibid.) “Policymakers,” the study

concluded, should “be wary of broad claims about economic effects

of pharmaceutical liability, including generalizations based on

anecdotes or examples.” (Id. at p. xv.)13

* * *

12 (See Steven Garber, Rand Institute for Civil Justice, Economic Effects of Product Liability and Other Litigation Involving the Safety and Effectiveness of Pharmaceuticals (2013), at p. xv <http://www.rand.org/content/dam/rand/pubs/monographs/MG1200/MG1259/RAND_MG1259.pdf> [as of Feb. 15, 2017].)

13 (See also Huck, supra, 850 N.W.2d at p. 399 (conc. & dis.

opn. of Hecht, Wiggins, and Appel, JJ.) [citing RAND study and stating that “[t]he majority’s claim that the pharmaceutical industry will be substantially harmed by a rule imposing a duty on the brands, who controlled the content of the warning PLIVA was legally required to use, is…speculative and overblown”].)

- 39 -

Amici have offered no reason for this Court to deviate from

Carlin or ignore the findings of the RAND report. They rely on

scare tactics and conjecture, while ignoring the benefits brand-

name manufacturers gain from selling their products on the

market, and that they continue to reap even after their drugs “go

generic.” This Court should not leave prescription drug

consumers unprotected and uncompensated based on so thin a

reed.

d. Availability of Insurance.

Amici also argue that brand-name manufacturer liability

for injuries caused by generic drugs—liability they characterize

as “innovator” or “pioneer” liability—would be “uninsurable.”

This argument fails because it rests on a false premise—

that Plaintiffs seek to punish “faultless” brand-name

manufacturers whose sole “offense” is bringing the particular

drug at issue to the market. (E.g., PLAC Br. at p. 32 [“By

contrast, innovator liability as urged by Plaintiffs is

uninsurable.”].) But, again, Plaintiffs’ claims rest instead on the

assertion that Novartis negligently failed to update the Brethine

label while it still owned the drug.

- 40 -

So long as the insured’s liability is premised on its own

negligent acts or omissions, the mere fact that the claimants may

never have been one of the insured’s patrons is irrelevant from a

legal—and thus, insurance—perspective. (Kesner, supra, 1

Cal.5th at pp. 1163 [“[W]e have never held that such a

relationship is a perquisite to finding that a defendant had a duty

to prevent injuries to its own conduct or possessory control.”].)

Here again, Carlin is instructive. If brand-name

manufacturers are able to secure insurance for claims arising out

of their strict liability failure to warn of “scientifically knowable”

risks—and there is no indication they have been unable to do

so—they should have little trouble securing insurance against

claims arising out of their negligent failure to warn regarding

risks about which they knew or should have known.

C. Amici’s Out-of-State Authority is Distinguishable or Unpersuasive.

Like Novartis, amici argue that, by imposing liability on

brand-name manufacturers for injuries caused by generic forms

of their drugs, California is at odds with the vast majority of

courts in other jurisdictions to consider the issue. (E.g., PLAC,

pp. 14–15.) But as in Kesner, a closer examination reveals that

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these out-of-state authorities “are readily distinguishable”

because they arose in jurisdictions that do not have “general tort

law principles commensurate with [California’s].” (Kesner, supra,

1 Cal.5th at p. 1163.)

For example, because “foreseeability [i]s the predominant

factor in duty analysis” in California (ibid.), Kesner rejected

several out-of-state cases on the simple ground that they

“downplayed the significance of foreseeability” in “the

establishment of a duty.” (Id. at p. 1162.) This fatal distinction is

also true of several of amici’s cases, including the Iowa Supreme

Court’s narrow 4-3 decision on which amici heavily rely.14

Similarly, because a pre-existing relationship between

plaintiff and defendant is not a prerequisite to negligence liability

in California (Kesner, supra, 1 Cal.5th at pp. 1163), in Kesner this

Court rejected cases that “asserted as a foundational principle of

tort liability that a plaintiff and a defendant must have a prior

14 (See Huck, supra, 850 N.W.2d at p. 376 [“In Thompson, we said that foreseeability should not enter into the duty calculus but should be considered only in determining whether the defendant was negligent.”]; see also Colaccio v. Apotex, Inc. (E.D. Pa. 2006) 432 F.Supp.2d 514, 543 [applying Pennsylvania tort law under which, in contrast to other states, “foreseeability is [not] the principal determinant of duty,” citing Althaus v. Cohen (2000) 562 Pa. 547)].)

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relationship for a duty to exist from the latter to the former.” (Id.

at p. 1162.) Yet, several of amici’s cited authorities rest on the

premise that a plaintiff and a defendant must have a prior

relationship for a duty to exist from the latter to the former.15

“Another significant difference” between California law and

the states from which amici draw their cases “is the availability

in California of a claim for negligence misrepresentation.” (Short,

supra, 2009 WL 9867531, p. 8.) Indeed, many of amici’s decisions

15 (Moretti v. Wyeth (9th Cir. 2009) 579 F. App’x 563, 564

[holding that, under Nevada law, a negligence misrepresentation claim “‘requires, at a minimum, some form of relationship between the parties’”]; accord Baymiller v. Ranbaxy Pharmaceuticals, Inc. (D. Nev. 2012) 894 F.Supp.2d 1302, 1311; Moretti v. Wyeth, Inc. (D. Nev. 2009, No. 2:08–cv–00396) 2009 WL 749532, p. 3; see also Schrock v. Wyeth, Inc. (10th Cir. 2013) 727 F.3d 1273, 1282–1283 [holding that, under Oklahoma law, “‘[w]hether or not a duty exists depends on the relationship between the parties,’” and yet “the brand-name manufacturers had no relationship with the Schrocks”]; Mensing v. Wyeth, Inc. (8th Cir. 2009) 588 F.3d 603, 613 [“[U]nder Minnesota law negligent misrepresentation requires the plaintiff to ‘prove some relationship that is sufficient to create a duty owed by the defendant to the plaintiff.’”]; Foster v. American Home Products Corp. (4th Cir. 1994) 29 F.3d 165, 171 [“The duty required for the tort of negligent misrepresentation arises when there is ‘such a relation that one party has the right to rely for information upon the other, and the other giving the information owes a duty to give it with care.’”]; Short v. Eli Lilly & Co. (Ind. Sup. Ct. Mar 25, 2009, No. 49D12-0601-CT-2187) 2009 WL 9867531, p. 8 [“In contrast, under Indiana law a duty does not arise unless there is a relationship between the parties.”].)

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were issued by courts sitting in states that maintain blanket

prohibitions on negligent-misrepresentation claims that are

inconsistent with California law.16

But perhaps the most important distinction in amici’s cited

cases is that many were issued in states with “Product Liability

Acts” that (1) expressly define any case involving a product-

caused injury as a “products-liability case” regardless of the

theory pleaded, and (2) expressly limit liability in a product-

liability case to manufacturers of the product at issue. This

16 (See, e.g., Huck, 850 N.W.2d at p. 371 [holding that courts applying Iowa law “have refused to allow a suit for negligent misrepresentation where the defendant was a retailer in the business of selling and servicing merchandise”]; Moretti, supra, 2009 WL 749532, at p. 3 [“Indeed, Nevada has expressly rejected the tort [of negligent misrepresentation] in cases such as this, where Plaintiff seeks recovery for personal injuries.”]; Baymiller, supra, 894 F.Supp.2d at p. 1311 [same]; Short, supra, 2009 WL 9867531, p. 8 [“Indiana does not recognize the tort of negligent misrepresentation except in the limited context of emoloyee/employeer relationships. Furthermore, Indiana law does not recognize any cause of action for misrepresentation that is baesd on representations made to third parties.”]; Flynn v. American Home Products Corp. (Minn. Ct. App. 2001) 627 N.W.2d 342, 351 [“[T]he Minnesota Supreme Court has recognized negligent misrepresentation involving damages only for pecuniary loss, and has expressly declined to recognize the tort of negligence misrepresentation involving the risk of physical harm.”]; Mensing, supra, 588 F.3d at p. 613 [“As for Mensing's negligent misrepresentation claim, ‘the Minnesota Supreme Court has recognized negligent misrepresentation involving damages only for pecuniary loss[.]’”].)

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significant distinction from California’s product liability law

applies to at least 19 of the 40 or so state and federal decisions

amici collectively cite.17

In recounting the contrary decisions from other

jurisdictions, amici place special emphasis on the fact that “every

federal court of appeal to consider the issue has held that brand-

name manufacturers are not liable to plaintiffs who are injured

by a generic’s drug.” (Strayhorn v. Wyeth Pharmaceuticals, Inc.

(6th Cir. 2013) 737 F.3d 378, 406.)

That statistic sounds impressive until one realizes that all

of those federal appellate decisions were the direct result of state

tort law that is fundamentally at odds with California’s. As noted

17 (Sheeks v. American Home Products Corp. (Dist. Ct. Colo.

Oct. 15, 2004, No. 02CV337) 2004 WL 4056060, p. 1; Short v. Eli Lilly & Co. (Ind. Sup. Ct. Mar. 25, 2009, No. 49D12-0601-CT-2187) 2009 WL 9867531, p. 8; Anselmo v. Sanofi–Aventis Inc. (Kan. Dist. Ct. Oct. 13, 2014, No. 10-CV-77) 2014 WL 8849464, pp. 1–2; Stanley v. Wyeth (La. Ct. App. 2008) 991 So.2d 31, 33–34; Franzman v. Wyeth (Mo. Ct. App. 2014) 451 S.W.3d 676, 689; Gardley-Starks v. Pfizer, Inc. (N.D. Miss. 2013) 917 F.Supp.2d 597, 602; Washington v. Medicis Pharmaceuticals Corp. (S.D. Miss. Feb. 7, 2013, No. 3:12cv126) 2013 WL 496063, p. 2; Phelps v. Wyeth (D. Or. 2012) 857 F.Supp.2d 1114, 1121; Burke v. Wyeth, Inc. (S.D. Tex. Oct. 29, 2009, No. G-09-82) 2009 WL 3698480, p. 3; Finnicum v. Wyeth, Inc. (E.D. Tex. 2010) 708 F.Supp.2d 616, 619; Hardy v. Wyeth, Inc. (E.D. Tex. Mar. 8, 2010, No. 9:09CV152) 2010 WL 1049588, p. 4.)

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above, four were based on state laws that conditioned duty

analysis on a relationship between the defendant and plaintiff

(see Moretti, supra, 579 F. App’x at p. 564; Mensing, supra, 588

F.3d at p. 613; Schrock, supra, 727 F.3d at pp. 1282–1283; Foster,

supra, 29 F.3d at p. 171), or categorically prohibited negligent-

misrepresentation claims for personal injury. (Mensing, supra,

588 F.3d at p. 613.) The balance of the federal appellate decisions

arose out states that, unlike California, had a codified “Product

Liability Act.”18

Of course, decisions in states with “Product Liability Acts”

are irrelevant here because, as even some of the courts that

departed from Conte have noted, “California does not have a

statute … that governs all claims brought for physical harm

allegedly caused by a product and that specifically limits liability

18 (Johnson v. Teva Pharmaceuticals USA, Inc. (5th Cir.

2014) 758 F.3d 605, 615; Eckhardt v. Qualitest Pharmaceuticals, Inc. (5th Cir. 2014) 751 F.3d 674, 678; Lashley v. Pfizer, Inc. (5th Cir. 2014) 750 F.3d 470, 476–478; Demay v. Scharz Pharma, Inc. (5th Cir. 2012) 702 F.3d 177, 182–183; Strayhorn, supra, 737 F.3d at pp. 401–403; Smith v. Wyeth, Inc. (6th Cir. 2011) 657 F.3d 420, 423; Fullington v. Pfizer, Inc. (8th Cir. 2013) 720 F.3d 739, 744; Bell v. Pfizer, Inc. (8th Cir. 2013) 716 F.3d 1087, 1092–1093; see also In re Darvocet, supra, 756 F.3d at pp. 941–953 [Arkansas, Connecticut, Louisiana, North Carolina, Ohio, and Washington Product Liability Acts].)

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to manufacturers or sellers of the alleged injury-causing product.”

(Short, supra, 2009 WL 9867531, p. 8; see also Anselmo, supra,

2014 WL 8849464, p. 2 [“California product liability law differs

from the significant majority of the states, including Kansas, in

that it does not ‘collapse’ all theories of recovery into a single

product liability claim.”].)19

The balance of amici’s decisions appear to rest at least in

part on the false premise that generic drug manufacturers have

the ability to unilaterally update an inadequate warning label.

This includes the Fourth Circuit in Foster itself, district courts

sitting in the Fourth Circuit,20 and a line of Florida cases that all

19 Indeed, the fact that so many states rely on statutes to

expressly “collapse” any claims for product-caused injuries into “product liability claims,” and then expressly limit such claims to the manufacturer of seller of that product, is at least a tacit admission of Plaintiffs’ earlier point that, left unfettered, the tort principles reflected in the Restatement of Torts would permit negligent-misrepresentation claims against a company other than the manufacturer of the product at issue so long as the causal nexus between that company’s misrepresentations and the plaintiff’s resulting injuries is foreseeable. (See, e.g., Stanley, supra, 991 So.2d at pp. 33–34 [characterizing state “Product Liability Acts” as “preempting” negligent-misrepresentation claims].)

20 (See, e.g., Fisher v. Pelstring (D.S.C. July 28, 2010, No.

4:09-cv-00252-TLW) 2010 WL 2998474, p. 6 [“[T]his Court is bound by the Fourth Circuit’s holding in Foster.”]; see also Meade v. Parsley (S.D. W.Va. Nov. 13, 2009, No. 2:09-cv-00388) 2009 WL

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directly or indirectly relied on Sharp v. Leichus (Fla. Cir. Ct. Feb.

17, 2006, No. 2004-CA-0643) 2006 WL 515532), an unpublished

opinion resting, in turn, on the false premise that, “under Florida

law, all pharmaceutical manufacturers, including generic

manufacturers, are obligated to ensure the accuracy of their own

warning information.” (Id. at p. 7.)21

In short, virtually all of the foreign cases on which amici

rely are either the product of a flawed understanding of federal

drug law or, more commonly, the product of state tort law that is

fundamentally different from California’s insofar as those states

(1) do not place the same emphasis on foreseeability in assessing

duty as do California courts, (2) condition a duty on the existence

of a relationship between plaintiff and defendant, (3) maintain

blanket prohibitions on the tort of negligent misrepresentation

that are alien to California, and/or (4) have codified a “Product

Liability Act” which expressly limits any claims for a product- 3806716, p. 3; Gross v. Pfizer, Inc. (D. Md. Nov. 9, 2010, No. 10-CV-00110-AW) 2010 WL 4485774, p. 2.)

21 (Metz v. Wyeth, Inc. (M.D. Fla. 2011) 830 F. Supp. 3d

1291, 1293; Levine v. Wyeth, Inc. (M.D. Fla. 2010) 684 F.Supp.2d 1338, 1343; Howe v. Wyeth, Inc. (M.D. Fla. Apr. 26, 2010, No. 8:09-CV-610-T-17AEP) 2010 WL 170885, p. 3; see also Guarino v. Wyeth, LLC (11th Cir. 2013) 719 F.3d 1245, 1251; Tsavaris v. Pfizer, Inc. (S.D. Fla. 2016) 154 F.Supp.3d 1327, 1339–1340.)

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caused injury to the manufacturer of that product. Because none

of those is true of California tort law, those decisions “are readily

distinguishable” (Kesner, supra, 1 Cal.4th at p. 303), as are any

decisions that rely on the now discredited premise that generic-

drug manufacturers can unilaterally change their own labels.

In contrast, courts that have applied tort principles

commensurate with California’s (Kesner, supra, 1 Cal.4th at p.

303)—and possess a proper understanding of the interplay of

federal drug law—have reached the same conclusion as the

California Court of Appeal. (See Wyeth, Inc. v. Weeks (Ala. 2014)

159 So.3d 649, 677; Dolin v. SmithKline Beecham Corp. (N.D. Ill.

2014) 62 F.Supp.3d 705, 713; Chatman v. Pfizer, Inc. (S.D. Miss.

2013) 960 F.Supp.2d 641, 654; Kellogg v. Wyeth, Inc. (D. Vt. 2010)

762 F.Supp.2d 694, 704; Clark v. Pfizer, Inc. (Pa. Ct. Co. Pl. 2008,

No. 1819) 2008 WL 7668730, p. 29.)22

22 This is not to mention that even among the contrary

authorities—including, most notably, the Sixth Circuit and the Iowa Supreme Court—the decision to depart from the rule expressed in Conte was not met with uniform approval. (See, e.g., Strayhorn, supra, 737 F.3d at p. 409–410 (dis. opn. of Stranch, J.); Huck, supra, (conc. & dis. opn. of Hecht, Wiggins, and Appel, JJ.)

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Thus, far from the outlier that amici’s massive string cites

suggest, the California Court of Appeal’s decisions in Conte and

below actually reflect the majority view—if not the unanimous

view—among courts that applied tort principles akin to

California’s.23

II. “Former” Manufacturer Liability is Consistent with California Tort Law.

The only remaining question is whether the fact that

Novartis off-loaded its mislabeled drug onto aaiPharma in 2001,

23 Amici also argue that imposition of liability on a brand-name manufacturer for injuries caused by a generic version of its product would undermine various aspects of federal law, including the Hatch–Waxman Act. (See generally Brief of Atlantic Legal Foundation (“ALF”).) These arguments were not raised below and are not properly before the Court. (See Professional Engineers in California Gov’t v. Kempton (2007) 40 Cal.4th 1016, 1047, fn. 12.).) They also lack merit. In particular, amici’s argument that suits like this one would conflict with the purposes of Hatch–Waxman—which, to Plaintiffs’ knowledge, has never been adopted by any court—ignores that the Hatch–Waxman Act is subject to the Food Drug and Cosmetic Act’s savings clause, which provides that state law may only be invalidated upon a “direct and positive conflict” with the FDCA. (See Wyeth, supra, 555 U.S. at p. 567, citing 21 U.S.C. § 321.) This provision, coupled with the absence of an express preemption clause in the FDCA and Congress’ “certain awareness of the prevalence of state tort litigation” surrounding all prescription drugs, supplies powerful “evidence that Congress did not regard state tort litigation as an obstacle to” the Hatch-Waxman Act. (Wyeth, supra, 555 U.S. at pp. 574–576; see also Kellogg, supra, 762 F.Supp.2d at pp. at 431–432 [rejecting preemption argument].)

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and therefore no longer held the NDA for Brethine at the time

Plaintiffs were brain damaged in utero, immunizes it from

liability under California law. When the question is evaluated

according to the Rowland factors, the answer is clearly no,

notwithstanding amici’s protestations to the contrary.

A. Foreseeability.

Amici don’t seriously argue that Novartis’s status as a

“former manufacturer” rendered Plaintiffs’ injuries unforeseeable

to it. This is not surprising, because as previously explained (see

ABOM at pp. 53), successor manufacturers who purchase the

brand rights from a predecessor manufacturer inherit—and are

bound to use—the label used by the outgoing manufacturer, with

all the inadequacies it might entail. (See 21 U.S.C. § 355; 21

C.F.R. § 314.105(b).) Thus, when it sold aaiPharma the NDA for

Brethine, Novartis knew aaiPharma was bound to use its label,

warts and all.

Amici also do not deny that it was just as foreseeable to

Novartis that aaiPharma would not update the label to disclose

the risk of the drug to the developing fetal brain. This is true not

only because it would be disingenuous for Novartis to deny the

foreseeability that another would do exactly that which Novartis

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itself just did, but particularly because adding such a warning

would have thoroughly devastated Brethine’s sales potential as a

tocolytic, which was, by then, responsible for at least half of

Brethine’s annual sales. (AA042.) Thus, aaiPharma’s own,

identical failure to add a warning to Brethine’s label regarding its

serious risks to fetal health was highly foreseeable to Novartis.24

B. Closeness of Connection.

Nor do amici dispute the closeness of the connection

between Novartis’s wrongdoing and aaiPharma’s own negligent

failure to update the Brethine label—which, in turn, led to the

Plaintiffs’ injuries. And for good reason: In Kesner, this Court

reaffirmed that, “[i]n determining whether one has a duty to

prevent injury that is the result of third party conduct, the

touchstone of the analysis is the foreseeability of that intervening

conduct.” (Kesner, supra, 1 Cal.5th at p. 1148.)

As just discussed, it was at least reasonably foreseeable to

Novartis that aaiPharma would not update the Brethine label.

24 The Rowland factor—the degree of certainty that the Plaintiffs’ suffered injury—does not depend on the defendant’s status as a “concurrent” brand-name manufacturer or a “former” manufacturer of the drug at issue. In either case, the question is the degree of certainty that Plaintiffs suffered injury (here, serious cognitive birth defects from prenatal exposure to Brethine).

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And because aaiPharma’s foreseeable failure to update the label

would not have “occurred” but for Novartis’s negligent failure to

add warnings to the Brethine label before it sold the NDA—

warnings aaiPharma would have been obligated to use (see

Wyeth, supra, 555 U.S. at p. 568; 21 C.F.R. § 314.70(c)(6)(iii)(A)–

(C))—aaiPharma’s subsequent failure to update the Brethine

label “do[es] not diminish the closeness of the connection between

[Novartis’s] conduct and [P]laintiff’s injury for purposes of

determining the existence of a duty of care.” (Kesner, supra, 1

Cal.5th at p. 1149, internal quotation marks omitted, quoting

Beacon Residential Community Assn. v. Skidmore, Owings &

Merrill LLP (2014) 59 Cal.4th 568, 583).)

C. Moral Blameworthiness of the Defendant.

Amici next argue that “former manufacturers” like

Novartis are somehow blameless, as though their sale of a

mislabeled drug to a successor company absolves them of their

sins. (E.g, Brief of National Association of Manufacturers, p. 19.)

In reality, however, there is little difference between a

“concurrent” brand-name manufacturer that has not yet updated

a drug label with a necessary warning and a “former” brand-

name manufacturer that negligently failed to do so. In either

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case, the manufacturer breached its federal duty to timely update

a drug label with the significant risk for serious physical injury to

unsuspecting consumers.

Indeed, if there is any difference in moral blame between a

“concurrent” and “former” brand-name manufacturer, the moral

blame is perhaps stronger as to the former manufacturer. Why?

Because the former manufacturer’s very status as a “former”

manufacturer means that more time has elapsed since its

negligent failure to update the label, with a corresponding

increase in the number of victims.

Using this case as an example, had Novartis updated the

Brethine label with a warning prior to divesting the Brethine

NDA in 2001, the drug would not have gone 10 years without that

warning, a warning that was only ever added by the FDA in 2011

in response to a citizen’s petition. (See supra note 12.) The

approximately two million additional children exposed to

Brethine between 2002 and 2011 thus places more moral blame

on Novartis’s shoulders than if Novartis had at least stopped the

bleeding by adding a necessary warning regarding fetal health

before it sold Brethine in December 2001. (See AA042 [alleging

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that, by 2001, Brethine was prescribed for tocolysis over 200,000

times per year].)

D. Burden on the Defendant.

Regarding burden, amici argue that it is impossible for

“former” manufacturers to comply with the standard of care

because once they relinquish the brand-rights to the drug, a

former brand-name manufacturer no longer has any control over

the label. (E.g., Brief Pacific Legal Foundation (“PLF”), p. 9.)

But in so arguing, amici fundamentally mischaracterize the

nature of Plaintiffs’ claims. Again, the gravamen of Plaintiffs’

claim is that Novartis should be held liable for the future,

foreseeable consequences of its negligent failure to update the

Brethine label with a necessary warning while it still owned the

brand. Plaintiffs do not suggest that Novartis is liable for

anything it did or did not do after it sold the Brethine NDA in

December 2001.

Thus, whether the defendant was a “concurrent” or

“former” manufacturer at the time the Plaintiffs were exposed to

the drug at issue, the relevant time period for “burden” analysis

remains the same—the brand-name manufacturer’s conduct

while it still owned the drug. (See Kesner, supra, 1 Cal.5th at p.

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1152 [holding that “burden” under Rowland “is forward-looking”

and focuses on “the cost to the defendants of upholding, not

violating the duty of ordinary care”].) And since federal law

already imposes a duty on brand-name manufacturers to monitor

data regarding potential adverse risks and update labels

accordingly, Plaintiffs’ proposed rule adds nothing that is not

already on a brand-name manufacturer’s plate by virtue of

federal law.

E. Prevention of Future Harm.

Regarding the prevention of future harm, amici first

attempt to argue that because Novartis did not own the Brethine

NDA at the time Plaintiffs’ mother was prescribed Brethine, and

therefore “no longer ha[d] any ability to avert the harm,” holding

Novartis liable for Plaintiffs’ injuries would not exert any

deterrent effect. (E.g., PLF Br., p. 9.)

But again, that argument is simply another manifestation

of amici’s fundamental mischaracterization of Plaintiff’s claims.

The focus of Plaintiffs’ operative complaint against Novartis is its

conduct when it still owned the Brethine brand, not its acts or

omissions thereafter. If Novartis’s failure to update the Brethine

labeling while Novartis still owned the drug was negligent, then

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holding Novartis liable for that failure would certainly have a

deterrent effect on Novartis and other similarly situated brand-

name manufacturers, even if they are not haled into court until

after they sold the misbranded “hot potato” drug to a successor.

Next, amici collectively spend dozens of pages rebutting an

argument Plaintiffs never made. Specifically, amici argue that

imposing liability on “former” manufacturers who sell a

mislabeled drug to a successor manufacturer is not necessary to

prevent successor manufacturers from being defrauded in the

purchase of a drug’s brand rights. To that end, amici emphasize

that “[t]he due diligence routinely undertaken in such

transactions, together with existing legal liability for misleading

would-be buyers,” would avoid successor manufacturers from

being misled regarding the liabilities inherent in the drug they

are buying. (E.g., PLAC Br., p. 3.)

But such arguments are wasted breath. Frankly, the

potential that a seller of a drug’s brand rights might dupe a buyer

into thinking it is buying a risk-free drug had not really occurred

to Plaintiffs and, in any event, was not even remotely a fixture of

Plaintiffs’ argument.

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To be clear, Plaintiffs do not suggest that by failing to

update the Brethine label with a warning regarding the drug’s

risk to fetal health that Novartis somehow duped aaiPharma. To

the contrary, Plaintiffs have always believed that aaiPharma

knew exactly what it was getting when it bought Brethine.

Rather, Plaintiffs are focused on public safety, and argue

that when Novartis sold its dangerously mislabeled drug to

aaiPharma, it increased the likelihood that Brethine would

remain dangerously mislabeled indefinitely because it was

reasonably foreseeable to Novartis that future manufacturers,

including aaiPharma, would similarly fail to update the Brethine

label.

This, of course, is precisely what happened in this case.

Plaintiffs allege that, based on the scientific data that had

already accumulated at the time, the Brethine label should have

included a warning regarding the risks to fetal health prior to

December 2001. But through negligence of several brand-name

manufacturers—including Novartis—the Brethine label was not

updated until 2011 when the FDA, in response to a citizen’s

petition filed in 2008, mandated the label update that Novartis

should have implemented 10 years earlier. (See, supra, note 12.)

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As a result, an untold number of children were needlessly injured

from prenatal Brethine exposure between at least 2002 and 2011.

And yet, because every subsequent Brethine manufacturer

would have invariably been stuck with a warning regarding risks

to fetal health had Novartis added one (see Wyeth, supra, 555

U.S. at p. 568; 21 C.F.R. § 314.70(c)(6)(iii)(A)–(C)), Novartis could

have prevented that cavalcade of injury at its source by adding a

such a warning to the Brethine label while it still owned the

drug.

As this case thus demonstrates, a brand-name

manufacturer who sells the rights to a mislabeled drug to a

successor manufacturer on the assumption that the successor will

“clean up the mess” is taking a serious gamble with consumers’

well-being. This is because the assumption that the successor

will “fix the problem” depends, in turn, on the assumption that

the successor will be a law-abiding, efficient actor who will not

only seek to identify deficiencies in the drug’s labeling and correct

them, but will do so with great haste.

But if either of these assumptions is wrong—if the

successor manufacturer is inefficient or, even worse, is tempted

to avoid adding the warning at issue based on the allure of profit

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from the sales that such a warning would jeopardize—then a

necessary warning would be at best delayed, if it ever appears at

all.

This is not an unrealistic concern. Indeed, of countless

examples that might be cited, it is perhaps no coincidence that

perhaps the two most “famous” cases in this area of the law—

Conte and Foster—both involved drugs that remained

dangerously mislabeled for decades despite passing from brand-

name manufacturer to brand-name manufacturer, all of whom

were charged with the duty to monitor, review, and respond to

data regarding potential health consequences of their drugs.

In Conte, for example, the plaintiff—who first began taking

metoclopramide in 2000—introduced evidence that, as early as

1985, drug manufacturers knew or should have known that long-

term use of metoclopramide could result in serious neurological

side effects. And yet, an adequate warning against such use did

not appear until 2009 when the FDA stepped in and mandated it.

(See Prescription for Fairness, supra, 60 Duke L.J. at pp. 1155–

1156, fn. 189.)

Similarly, in Foster, there was evidence that as early as

1969, manufacturers were already aware of reports that the

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active ingredient in Phenergan, a popular cough syrup, had

caused fatal respiratory distress in numerous children. (Id. at p.

1147.) And yet, no such warning against Phenergan’s use with

children appeared on its labeling information when generic

Phenergan was given to—and killed—six-week-old Brady Foster

in 1988. (Foster, supra, 29 F.3d at 167.)

Indeed, the epilogue to Foster provides a significant

cautionary tale about the public-health ramifications of a rule

that insulates brand-name manufacturers for liability for injuries

caused by generic drugs (as well as the dangers of relying on the

FDA to police drug labels). Even after the Foster’s now-infamous

lawsuit against American Home Products (the then-brand name

manufacturer of Phenergan), no one—including American

Home—made any effort to update the label with a warning

against use with children. Indeed, it was not until “a decade

after the Fourth Circuit’s decision” in Foster that the FDA finally

“announced that a boxed warning would be added to the drug to

bar it from being given to children less than two years of age.”

(Prescription for Fairness, supra, 60 Duke L.J., p. 1146–1147,

emphasis added.) One can only imagine the immense fury that

the parent of a child who died from Phenergan a month before

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the FDA’s announcement would have felt toward American

Home.

In short, a rule limiting a brand-name manufacturer’s

liability for failing to update a drug to only those injuries that

occur while the brand-name manufacturer still owns the NDA

would do nothing to discourage brand-name manufacturers who

know (or should know) that their product is dangerously

mislabeled from gambling with public health by selling the

brand-rights to a successor manufacturer who may—or, if history

is any indication, may not—move swiftly to provide the necessary

label update, if it provides one at all.

In fact, if anything, such a rule would only serve to

encourage manufacturers to delay or omit warnings where they

perceive a pecuniary advantage to doing so, such as where the

warning would jeopardize one of the drug’s predominant

therapeutic purposes. And history not only teaches that this very

thing in fact happens with an alarming frequency, but that the

consequences to life and health can be absolutely devastating

when it does.

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F. Consequences to the Community

Amici brush aside the health risks of imposing a categorical

ban on “former manufacturer” liability, arguing instead that

affirming the lower court’s ruling would give rise to a sort of

twilight zone of “perpetual liability,” in which brand-name drug

manufacturers could be sued “in perpetuity” for injuries caused

by their drugs. Amici argue this would stifle innovation and

backfire on consumers in all sorts of terrible ways.

As a threshold matter, given the examples in the preceding

discussion of cases where drug manufacturers’ negligence in

failing to provide necessary warnings caused serious injuries or

death over a period of several decades, from a public-safety

standpoint, one might wonder which way the specter of

“perpetual liability” cuts in the duty analysis. (See Kesner, supra,

1 Cal.5th at p. 1152 [“[S]hielding tortfeasors from the full

magnitude of their liability for past wrongs is not a proper

consideration in determining the existence of a duty.”].)

Nevertheless, there are stop-gap measures available to

brand-name manufacturers that may serve to mitigate, if not

eliminate, a former-manufacturer’s liability for injuries arising

after they sell the brand rights to a drug.

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For example, a defendant’s status as a “former”

manufacturer necessarily assumes that there will be at least

one—and, as time goes on, likely several other—brand-name

manufacturers who also negligently failed to update the warning

label at issue and who will therefore share in any fault for

injuries caused thereby. (See ABOM, p. 59, fn. 20.)

In addition, to insulate themselves from future liability,

rational brand-name manufacturers could—and likely would—

respond to a ruling of this Court affirming the decision below by

adding a term to the sale of any NDA under which the buyer

agrees to bear the liabilities of the seller for any subsequent

claims arising out of an alleged insufficient warning label after a

specific date (if not the purchase date). (E.g., Conte, supra, 168

Cal.App.3d at p. 95, fn. 1.) The effect of such agreements would

be to “funnel” liability for insufficient warning labels to the

current brand-name manufacturer.

Of course, to secure such an agreement, a company looking

to sell an NDA would be wise to exercise vigilance in monitoring

and updating its drug labels while it owns those drugs so as to

minimize the scope of liability a successor would face by

purchasing the drug. Otherwise, a negligent brand-name

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manufacturer would risk losing money on the sale of a drug’s

NDA as any rational successor would likely discount its purchase

price in light of the liabilities it might acquire by purchasing the

product line.

This outcome would thus satisfy those concerned about

public safety and “perpetual liability”: Brand-name

manufacturers would have a significant financial incentive to

ensure their labels are accurate and update to date, and yet

would offer them an avenue to mitigate the remote possibility of

being named in a lawsuit long after they divested the drug at

issue.

Tellingly, amici do not deny the intrinsic utility of either

method by which former manufacturers might avoid liability.

Rather, their primary response is to argue that these alternatives

would be of no help to a brand-name manufacturer who sells an

NDA to a successor that later becomes insolvent. (E.g., IADC &

FDCC, p. 10.) Admittedly, the facts of this case show that amici’s

concern is not implausible.

But a successor’s insolvency is a two-way street and would

have adverse consequences for the plaintiff as well, if for no other

reason than it ensures the plaintiff will invariably lose a portion

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of their noneconomic damages under Proposition 51. (Civ. Code, §

1431.2 [imposing several liability for noneconomic damages].) Of

course, as a corollary, Proposition 51 also means that any brand-

name manufacturer would still only pay its proportional share of

fault regardless of the solvency of a successor manufacturer.

In any event, the mere fact that an occasional successor

manufacturer may become insolvent should not justify a blanket

rule of immunity for all former brand-name manufacturers.

Indeed, this is particularly true when one remembers that this

“worst-case scenario” of an insolvent successor would only result

in liability to what is, at bottom, a negligent actor. (See Kesner,

supra, 1 Cal.5th at p. 1152 [“To the extent defendants argue that

the costs of paying compensation for injuries that a jury finds

they have actually caused would be so great that we should find

no duty to prevent those injuries, the answer is that shielding

tortfeasors from the full magnitude of their liability for past

wrongs is not a proper consideration in determining the existence

of a duty.”].)

Amici’s other response is to argue that Plaintiffs’ proposed

stop-gaps for “perpetual liability” are of diminished value because

“even unmeritorious claims can consume time and resources until

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they are disposed on summary judgment or rejected at trial.”

(IADC & FDCC, p. 10.)

Amici’s underlying premise is correct, but their ultimate

conclusion is not. For one, there is no reason the indemnification

agreements Plaintiffs envision need be limited to compensation

for settlements or judgments. Indeed, as is common in such

agreements, they could easily include provisions for attorneys’

fees and costs. This is not to mention that California law

contains mechanisms by which a defendant who ultimately

prevails against a meritless claim can recover most if not all of its

costs. (See Code Civ. Proc., §§ 998, 1032, 1033.5.)

More importantly, the fear that frivolous claims may follow

the creation of a duty of care could be said about any duty of care

that exists in California tort law. The mere specter that some

plaintiffs may pursue meritless claims is no justification to close

the courthouse doors to the many seriously injured plaintiffs with

legitimate ones.25

25 Amici also err in asserting that former-manufacturer

liability was expressly disclaimed in Conte in light of the potential for “perpetual liability.” (E.g., CJAC, p. 9; PLF, p. 6.) In fact, Conte implicitly assumed that its rule applies with equal force to “former” manufacturers. This is because Wyeth, the title defendant, sold the NDA for Reglan (the brand-name drug at

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G. Availability of Insurance.

Amici also argue that a “former” brand-name manufacturer

like Novartis would be unable to obtain insurance, but the only

things that distinguish such a case from one against a

“concurrent” brand-name manufacturer are (1) the passage of

time and (2) the subsequent negligent acts of one or more

successor manufacturers. Neither characteristic should convert

an insurable claim into an uninsurable one.

Nothing in California law suggests that the mere passage

of time between a negligent act and its harmful manifestations issue) to a successor—Schwarz—in December 2001. (Conte, supra, 168 Cal.App.4th at p. 95, fn. 1.) And yet, although the plaintiff alleged her injuries were “a result of taking [generic Reglan] for almost four years between August 2000 and April 2004” (id., at p. 95), Wyeth’s divesture of the Reglan NDA relatively early in that period received only passing mention in a footnote. (Id. at p. 94, fn. 1.)

Amici also mischaracterize Conte’s statement that “it appears Wyeth no longer has primary responsibility for Reglan-related claims arising after March 31, 2002.” (Ibid.) That sentence was not a reference to Wyeth’s divesture of the Reglan NDA, but rather a reference to the fact that, as part of the agreement to purchase of the Reglan NDA from Wyeth, Schwartz agreed to bear responsibility for any Reglan-related claims arising after March 31, 2002. Thus, the fact that Conte responded to Wyeth’s concerns regarding perpetual liability by citing to Schwarz’s contractual obligation to assume liability for future Reglan-related claims and not Wyeth’s divesture of the NDA implies that, in the Conte court’s mind, Wyeth’s divesture of the NDA did not immunize it for liability for its past misconduct.

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inherently affects the insurability of the resulting claim. Indeed,

California’s statutes of limitation supply ample indicia that

California law readily anticipates that there will often be even a

significant temporal gap between a negligent act and the

manifestation of injury—and, thus, a resulting insurance claim—

particularly in the healthcare industry.

For example, under California law, a lawsuit for injuries

caused to a person prior to or during their birth may be filed up

to “six years after the date of birth.” (Code Civ. Proc., § 340.4.)

And even then, that six-year limitations period does not actually

begin to run until the plaintiff (or, in the case of a minor, his or

her guardian) discovers the injuries that form the basis of the

lawsuit, which may take years. (See Rylaarsdam & Turner, Cal.

Practice Guide: Civil Procedure Before Trial—Statutes of

Limitation (The Rutter Group) ¶ 4:442, pp. 4-35 to 4-36.)

Similarly, the three-year limitations period for medical-

malpractice actions (see Civ. Code, § 340.5), does not begin to run

until the injury manifests. (Drexler v. Petersen (2016) 4

Cal.App.5th 1181, 1190.) In certain cases—such as a physician’s

negligent failure to appreciate the early signs of cancer—the lag

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between negligent act and resulting malpractice-insurance claim

can be lengthy.

Nor should the presence of other negligent actors—namely,

successor manufacturers who similarly failed to update the

label—alter the insurance calculus. It is bedrock California law

that, so long as the subsequent negligence was reasonably

foreseeable, an original tortfeasor remains liable for injuries

wrought in part through its negligence, even where those injuries

were only made possible—or were made worse—as a result of a

third-party’s subsequent negligence. (E.g., Kesner, supra, 1 Cal.

at p. 1148.) Indeed, in California, auto insurers are stuck with

the fact that it is foreseeable to their insureds as a matter of law

that anyone they strike with their car could be the victim of

medical malpractice during the ensuing medical treatment. (E.g.,

Blecker v. Wolbart (1985) 167 Cal.App.3d 1195, 1201.)

Ultimately, neither of the distinctions between a

“concurrent” and “former” brand-name manufacturer—the

passage of time or the involvement of other similarly, negligent

actors—should disturb the availability of insurance for claims

against brand-name manufacturers who negligently fail to

- 70 -

provide a necessary warning on their drug label while they still

controlled the drug.

* * *

In short, none of the Rowland factors counsels in favor of

creating a categorical immunity for “former” brand-name drug

manufacturers. Amici’s contention that “former” drug

manufacturers should receive total immunity from tort liability

under all circumstances simply because the imposition of liability

in some circumstances might not be fair or reasonable, even if a

defendant’s past misconduct bore a causal nexus to the plaintiff’s

injuries, has no support in the law and should be firmly rejected.

- 71 -

CONCLUSION

For the foregoing reasons, Plaintiffs pray this Court will

affirm the decision below and remand for further proceedings.

Dated: February 16, 17

By: /s/ Leslie A. Brueckner

Leslie A. Brueckner, Esq.

By: /s/ Benjamin I. Siminou Benjamin I. Siminou, Esq.

- 72 -

CERTIFICATE OF COMPLIANCE

As required by California Rules of Court, rule 8.520(c)(1), I

certify that, according to the word-count feature in Microsoft

Word, this “Plaintiffs’ Consolidated Answer to Amicus

Curiae Briefs filed in Support of Respondent,” contains

words 13,921, including footnotes, but excluding any content

identified in rule 8.520(c)(3).

Dated: February 16, 17

By: /s/ Benjamin I. Siminou Benjamin I. Siminou, Esq.

- 1 -

PROOF OF SERVICE

I, the undersigned, say: I am over 18 years of age, employed

in the County of San Diego, California, and not a party to the

subject cause. My business address is 2550 Fifth Ave., Ste. 1100,

San Diego, California, 92103.

On February 16, 2017, I served the attached “Plaintiffs’

Consolidated Answer to Amicus Curiae Briefs filed in

Support of Respondent,” of which a true and correct copy of

the document filed in the cause is affixed by placing a copy

thereof in a separate envelope for each addressee named

hereafter, addressed to each such addressee respectively as

follows:

See attached Service List

Each envelope was then sealed, and with the postage

thereon fully prepaid, deposited in the United States mail by me

at San Diego, California, on February 16, 2017.

I declare under penalty of perjury that the foregoing is true

and correct, and this declaration was executed at San Diego,

California, on February 16, 2017.

___________________________ Diane DeCarlo

PROOF OF SERVICE

I, the undersigned, say: I am over 18 years of age, employed

in the County of San Diego, California, and not a party to the

subject cause. My business address is 2550 Fifth Ave., Ste. 1100,

San Diego, California, 92103.

On February 16, 2017, I served the attached "Plaintiffs'

Consolidated Answer to Amicus Curiae Briefs filed in

Support of Respondent," of which a true and correct copy of

the document filed in the cause is affixed by placing a copy

thereof in a separate envelope for each addressee named

hereafter, addressed to each such addressee respectively as

follows:

See attached Service List

Each envelope was then sealed, and with the postage

thereon fully prepaid, deposited in the United States mail by me

at San Diego, California, on February 16, 2017.

I declare under penalty of perjury that the foregoing is true

and correct, and this declaration was executed at San Diego,

California, on February 16, 2017.

Diane DeCarlo

- 1 -

H. (T.) v. Novartis Pharmaceuticals Corporation Case Number 8233898

S erv ice List

Party

Defendant and Respondent Novartis Pharmaceuticals Corporation

Pacific Legal Foundation - Amicus curiae

Consumer Attorneys of California -Amicus curiae

American Association for Justice -Amicus curiae

Public Citizen - Amicus curiae

AARP - Amicus curiae

Attorney

Eric G. Lasker Katharine R. Latimer Hollingsworth LLP 1350 I Street, N.W., Ninth Floor Washington, DC 20005

Erin McCalmon Bosman Julie Yongsun Park Morrison & Foerster LLP 12531 High Bluff Drive, Suite 100 San Diego, CA 92130

Anastasia Paulinna Boden Pacific Legal Foundation 930 G Street Sacramento, CA 95814

Alan Charles Dell'Ario Attorney at Law 1561 Third Street, Suite B Napa, CA 94559

Alan Charles Dell'Ario Dell'Ario & LeBoeuf, PC 1561 Third Street, Suite B Napa, CA 94559

Nance Felice Becker Chavez & Gertler LLP 42 Miller Avenue Mill Valley, CA 94925

William Alvarado Rivera AARP Foundation Litigation 601 E. Street, NW Washington, DC 20049

H. (T.) v. Novartis Pharmaceuticals Corporation Case Number S233898

Serv ice List

Party

AARP Foundation - Amicus curiae

Pharmaceutical Research and Manufacturers of America - Amicus curiae

Washington Legal Foundation -Amicus curiae

Product Liability Advisory Council, Inc. - Amicus curiae Attn: Hugh F. Young, Jr. 1850 Centennial Park Drive, Suite 510 Reston, VA 20191

International Association of Defense Counsel and Federation of Defense & Corporate Counsel - Amicus curiae

Chamber of Commerce of the United States of America - Amicus curiae

Attorney

William Alvarado Rivera AARP Foundation Litigation 601 E. Street, NW Washington, DC 20049

Jeffrey Michael Davidson Covington and Burling LLP One Front Street, Floor 35 San Francisco, CA 94111

Gregory Herbers Washington Legal Foundation 2009 Massahusetts Avenue, NW Washington, DC 20036

David E. Stanley Reed Smith LLP 355 South Grand Avenue, #2900 Los Angeles, CA 90071

Mary-Christine Sungaila Haynes and Boone, LLP 600 Anton Boulevard, Suite 700 Costa Mesa, CA 92626

Kannon K. Shanmugam Connor S. Sullivan Allison Jones Rushing Williams & Connolly LLP 725 Twelfth Street, N.W. Washington, DC 20005

H. (T.) v. Novartis Pharmaceuticals Corporation Case Number S233898

Service List

P arty A ttorney

Civil Justice Association of California Fred J. Hiestand - Amicus curiae Attorney at Law

3418 Third Avenue, Suite 1 Sacramento, CA 95817

National Association of Manufactures Paul B LaScala - Amicus curiae Gabriel Scott Spooner

Shook Hardy & Bacon LLP 5 Park Plaza, #1600 Irvine, CA 92614

American Tort Reform Association - Paul B LaScala Amicus curiae Gabriel Scott Spooner

Shook Hardy & Bacon LLP 5 Park Plaza, #1600 Irvine, CA 92614

The Atlantic Legal Foundation - Robert P. Charrow Amicus curiae Anna B. Laakmann

Greenberg Traurig LLP 2101 L. Street, N.W. Washington, DC 20037

Genentech, Inc. - Amicus curiae Alicia Jane Donahue Shook Hardy & Bacon, LLP One Montgomery Tower, Suite 2700 San Francisco, CA 94104

California Life Sciences Association - Alicia Jane Donahue Amicus curiae Shook Hardy & Bacon, LLP

One Montgomery Tower, Suite 2700 San Francisco, CA 94104

San Diego County Superior Court Hon. Joan M. Lewis 330 West Broadway San Diego, CA 92101

H. (T.) v. Novartis Pharmaceuticals Corporation Case Number 8233898

Party

Ser v ice List

Attorney

Clerk of the Court Fourth District Court of Appeal Division One 750 B Street, Suite 300 San Diego, CA 92101